Leading drug makers Dr Reddy’s Laboratories, Cipla, Emcure Pharmaceuticals, Sun Pharmaceutical Industries and Torrent Pharmaceuticals have decided to collaborate for clinical trial of the investigational oral antiviral drug Molnupiravir for the treatment of mild COVID-19.
The five pharma companies have entered into a collaboration agreement, wherein the parties will jointly sponsor, supervise and monitor the clinical trial in the country, according to regulatory filings by Dr Reddy’s and Cipla.
As per the directive of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation, Dr Reddy’s will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr Reddy’s in its clinical trial, the filings noted.
The clinical trial will be conducted for the treatment of mild COVID-19 in an outpatient setting and is expected to take place between June and September across India with the recruitment of 1,200 patients, they added.
Such collaboration for a clinical trial is a first of its kind within the Indian pharma industry, and will aim to investigate yet another line of treatment in the collective fight against the COVID-19 pandemic, the companies noted.
On successful completion of the clinical trial, each company will independently approach the regulatory authorities for approval to manufacture and supply Molnupiravir for the treatment of COVID-19 in India, it added.
Molnupiravir is an oral antiviral drug that inhibits the replication of multiple RNA viruses including SARS-CoV-2.
It is currently being studied by MSD, through a collaboration with Ridgeback Biotherapeutics, in a Phase Ill trial for the treatment of non-hospitalised patients with confirmed COVID-19 globally.
Between March and April this year, the five Indian pharma companies had individually entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low- and middle-income countries.
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